Compounding System

Based on advanced equipment manufacturing and automation architecture concepts, we design and manufacture sterile liquid preparation modules suitable for media/buffer preparation, inactivation, emulsification, sterile preparation, and other processes.

Based on advanced pharmaceutical process concepts and rich experience in automated production,  A&M Technology Co., Ltd has launched a modular system SKID for aseptic liquid preparation production. It has a compact structure, highly integrated automation, and functional modularity, and can meet various needs of GMP production. Suitable for medium/buffer preparation, sterile preparation production, complex liquid preparation production, etc.  

●Working volume: 15L-5000L
●Main components such as liquid mixing tanks, magnetic stirring, pipes, valves and instruments are all selected from domestic and foreign high-quality brands
●3D modular design, compact and beautiful appearance, humanized design, easy to operate and maintain
●PLC/DCS control, programming configuration based on ISA-88 standard, realizing Batch control
●Fully automatic design, including CIP/SIP, process parameter control, etc.
●Full-color integrated IPC, easy to operate while ensuring compliance with 21CFR PART11
●Flexible adapter board design
●All component materials comply with clean area requirements and are resistant to environmental sterilization
 

●Aseptic design: priority is given to magnetic stirring to ensure zero leakage; all branch valves meet the 3D principle; no residue design, integrated non-dead angle valves are used at key positions; CIP/SIP fully automatic design, automatic tank pressure.
●Fully automatic design: It can realize the automation of the whole process including sampling, reduce the intensity of personnel operation and reduce the probability of misoperation, while enhancing the traceability of the process and facilitating audit tracking.
●Control system: Based on in-depth development of Siemens PLC, and equipped with brand touch screen for human-computer interaction operation. Provides PLC/DCS options to achieve production line-level control; configuration is based on ISA-88 standards to achieve batch control; compatible with MES and other intelligent management software; supports remote Web access, can realize WEB publishing functions, and can be used through computers Or use mobile devices (tablets, smartphones) to remotely access the system within the local area network, or under the public network authorized by VPN, to monitor the status and parameters of the system in real-time, which facilitates management while ensuring the security and confidentiality of the system.

Comply with FDA21CFR PART11 electronic signature and audit trail requirements, and meet data integrity requirements.
●Verification documents: Provide a full set of verification documents including CSV to ensure full life cycle compliance from product design, engineering implementation and use.